MAUDE Adverse Event Report: ABON BIOPHARM (HANGZHOU) CO., LTD. STREP A RAPID TEST STRIP (THROAT SWAB)

Catalog Number IST-501

Device Problem False Negative Result (1225)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2023

Event Type  Death  

Event Description

The manufacturer was informed by the distributor of a false negative result reported by a medical professional using the biosynex strep a rapid test strip (throat swab) catalog number ist-501, lot 0000639258.The reporter stated that a doctor performed a strep a test on a patient and the test result was negative.The patient was reported to have died an unknown period of time after the result was obtained.The reporter relayed that the patient death was caused by a streptococcus pyrogenes infection.The reporter will not provide any further information.

Manufacturer Narrative

1.Based on consultation with the senior director of medical, scientific and clinical affairs, there was no clear association between the false negative strep a result and the patient passing away.Due to limited information to make a definitive conclusion.Although there is no direct information that indicates that the false negative test result caused or contributed to the patient death, this mdr is being submitted conservatively because a contribution could not be ruled out.2.Death occurred; however, the cause is unknown.At the time of this report, the patients died after testing false (negative - edited) but there is no suspected relationship between the death and the use of the product.3.This report is being filed on an international product, biosynex s.A.Strep a rapid test strip , marketed in france, which is same/similar to strep a rapid test strip marketed in the us under listing number e647599, 510(k) k010582.Biobyex strep a (complained product) and strep a rapid test strip for throat swab specimen under listing number e647599, 510(k) k010582 use different product names, but share the same internal catalogue ist-501d because same formulation.So they are considered as similar products.4.The date indicated in b3 date of death confirmed is an approximation as the exact event date was not provided.12sep2023 is the date of the official written statement and date of event is not known, so use the 1st day of the reported month-01sep2023.5.Investigation summary: the batch record was reviewed and no deviation as observed.The retain product was performed and no false negative result was observed.

• Brand Name: STREP A RAPID TEST STRIP (THROAT SWAB)
• Type of Device: STREP A RAPID TEST STRIP (THROAT SWAB)
• Manufacturer (Section D): ABON BIOPHARM (HANGZHOU) CO., LTD.; #198 12th street east; economic and technological; hangzhou 31001 8; CN 310018
• Manufacturer Contact: grant bin zhang ; #198 12th street east; economic and technological; hangzhou 31001-8 ; CN 310018 ; 5718163802
• MDR Report Key: 18976343
• MDR Text Key: 338546647
• Report Number: 3005641941-2024-00002
• Device Sequence Number: 1
• Product Code: GTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IST-501
• Device Lot Number: 0000639258
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death